Adicet Bio Announces Oral Presentation of Updated ADI-001 Phase 1 Data at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 27, 2022 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapies for cancer, reported that updated safety and efficacy data from the Phase 1 study of ADI-001 for the potential treatment of relapsed or refractory B-cell Non-Hodgkin’s Lymphoma (NHL) will be delivered as an oral presentation at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago and online June 3-7, 2022 (Press release, Adicet Bio, APR 27, 2022, View Source [SID1234613073]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the oral presentation are as follows:
Abstract Number: 7509
Abstract Title: A phase 1 study of ADI-001: Anti-CD20 CAR-engineered allogeneic gamma delta (γδ) t cells in adults with B-cell malignancies
Presenting Author: Sattva Neelapu, MD, MD Anderson Cancer Center
Session Type/Title: Clinical Science Symposium/ Beating Bad Blood: The Power of Immunotherapy in Hematologic Malignancies
Date: June 6, 2022
Time: 8:00 AM-9:30 AM CDT

The abstract will be available on Thursday, May 26 at 5:00 PM EDT on ASCO (Free ASCO Whitepaper).org.

EXACT Therapeutics AS announces the publication of its 2021 Annual Report

On April 27, 2022 EXACT Therapeutics AS ("EXACT-Tx", Euronext Growth: EXTX), a clinical stage biopharmaceutical company with a mission to enhance the therapeutic efficacy of medicines through ultrasound-mediated drug delivery, reported that its Board of Directors has approved the Annual Report including the Annual Financial Statements for the year ended 31 December 2021 (Press release, Exact Therapeutics, APR 27, 2022, View Source [SID1234613148]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Annual Report for 2021 is also available on the Company’s website: View Source

Posted Financial Results for FY2021

On April 27, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, "the Company") reported the financial results for fiscal year 2021 (FY2021) ended March 31, 2022 (Press release, Astellas, APR 27, 2022, View Source [SID1234613006]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

1. Overview of business performance and others
(1) Overview of business performance for FY2021
1) Overview of consolidated financial results for FY2021 Consolidated financial results (core basis) in FY2021 are shown in the table below. While revenue increased, core operating profit and core profit for the year decreased

Established a new account, which includes gain on sale of rights of in-market products or pipeline assets, in the third quarter of FY2021

Revenue
-Main products XTANDI for the treatment of prostate cancer, XOSPATA for the treatment of acute myeloid leukemia, PADCEV for the treatment of urothelial cancer and EVRENZO for the treatment of renal anemia showed steady growth. In addition, the sales growth of Betanis / Myrbetriq / BETMIGA for the treatment of overactive bladder ("OAB") and EVENITY for the treatment of osteoporosis contributed to revenue growth as well.
-Moreover, another factor for the increase in sales in FY2021 was the sales of pharmacologic stress agent Lexiscan returning to pre-pandemic levels which decreased mainly in the first quarter of the previous fiscal year by the impact of the spread of COVID-19.
-The sales growth of the products above offset the sales decrease mainly due to the termination of sales agreements for Celecox for the treatment of inflammation and pain and Lipitor for the treatment of hypercholesterolemia, and the divestiture of Eligard for the treatment of prostate cancer. As a result of the above, revenue in FY2021 increased by 3.7% compared to those in the previous fiscal year ("year-on-year") to ¥1,296.2 billion. Core operating profit / Core profit for the year-Gross profit increased by 4.0% year-on-year to ¥1,043.2 billion. The cost-torevenue ratio fell by 0.2 percentage points year-on-year to 19.5%, mainly due to changes in product mix, despite the foreign exchange rate impact from the elimination of unrealized gains in intra-group transactions.-Selling, general and administrative expenses increased by 8.8% year-on-year to ¥548.8 billion.

The total amount increased mainly due to the impact of the foreign exchange rates (increase of ¥25.0 billion year-on-year), the increase of copromotion fees associated with the growth of sales of XTANDI in the United States (increase of ¥11.3 billion year-on-year), investment in Digital Transformation (increase of approximately ¥8.0 billion year-on-year), and the increase in sales promotion expenses for new product launch readiness (increase of approximately ¥5.0 billion year-on-year), despite a decrease in expenses due to the global optimization of personnel aligned with transformation of product portfolio (decrease of approximately ¥9.0 billion year-on-year). Selling, general and administrative expenses, excluding co-promotion fees of XTANDI in the United States, increased by 6.6% year-on-year to ¥409.5 billion.

-Research and development (R&D) expenses increased by 9.6% year-on-year to ¥246.0 billion. The total amount increased mainly due to the impact of the foreign exchange rates and also increases in development expenses for zolbetuximab, an anti-Claudin 18.2 monoclonal antibody and R&D investment for Rx+ business (related to iota).
-Amortisation of intangible assets increased by 19.0% year-on-year to ¥28.3 billion. 3-Gain on divestiture of intangible assets was ¥24.2 billion, including transfer of five products to Cheplapharm which were sold in Europe and other regions (¥12.3 billion), transfer of a pipeline asset (¥9.2 billion) and transfer of Bendamustine (¥2.0 billion) in the third quarter of FY2021.

As a result of the above, core operating profit decreased by 2.6% year-on-year to ¥244.7 billion, and core profit for the year decreased by 9.2% year-on-year to ¥190.6 billion. Impact of exchange rate on financial results The exchange rates for the yen in FY2021 are shown in the table below.

The resulting impacts were a ¥59.6 billion increase in revenue and an ¥18.5 billion increase in core operating profit compared with if the exchange rates of FY2020 were applied.

Tempest Announces Oral and Poster Presentations at the Upcoming 2022 ASCO Annual Meeting

On April 27, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing therapeutics that combine both targeted and immune-mediated mechanisms, reported that two abstracts were accepted for presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022 at the McCormick Place Convention Center in Chicago, IL (Press release, Tempest Therapeutics, APR 27, 2022, View Source [SID1234613025]). The results of the Phase 1 monotherapy and Phase 1 combination therapy studies with TPST-1120, a potential first-in-class PPARα antagonist, received an invitation for an oral presentation. The trial results will be presented on the podium by Mark Yarchoan, a clinical investigator from Johns Hopkins School of Medicine.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In addition, the trials-in-progress abstract for TPST-1495, a potential first-in-class EP2/EP4 prostaglandin receptor dual antagonist, was accepted for a poster presentation.

"We are thrilled that ASCO (Free ASCO Whitepaper) recognized our two novel clinical programs and accepted the abstracts for presentation," commented Stephen Brady, chief executive officer of Tempest. "This will be the first presentation of clinical data from a Tempest program, and we are encouraged by the results from our completed Phase 1 study with TPST-1120, and excited about the ongoing first-line randomized study in patients with hepatocellular carcinoma."

Our abstracts will be released on Thursday, May 26, 2022 at 5:00 p.m. EDT on ASCO (Free ASCO Whitepaper).org/abstracts. We expect to also include data from the additional TPST-1120 patients enrolled after abstract submission.

Presentation details:

Title: A phase 1 study of TPST-1120 as a single agent and in combination with nivolumab in subjects with advanced solid tumors.

Session Typer/Title: Oral Abstract Session, Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Date and Time: Tuesday, June 7, 2022; 9:45 a.m. – 12:45 p.m. CDT
Abstract Number: 3005

Title: A phase 1 study of TPST-1495 as a single agent and in combination with pembrolizumab in subjects with solid tumors

Session Type/Title: Poster Session, Developmental Therapeutics – Immunotherapy
Session Date and Time: Sunday, June 5, 2022; 8:00 a.m. – 11:00 a.m. CDT
Abstract Number: TPST2696

Complete enrolment lead candidate FMPV-1 phase I study

On April 27, 2022 Hubro Therapeutics reported that enrolment to cohort 2 (8 subjects) is completed and that all subjects have received their initial doses in the company’s phase 1 trial with FMPV-1 in healthy volunteers (Press release, Hubro Therapeutics, APR 27, 2022, View Source [SID1234613041]). Due to the high proportion of subjects with early detected T cell mediated immune responses seen in cohort 1, cohort 2 is being conducted with the same dose as used cohort 1. To date, FMPV-1 has been very well tolerated and it is expected that the immune responses should be relevant in MSI-H colorectal and gastric cancer. Data on cohort 2 immune responses are expected in Q2.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!